The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children

Sponsor

Bait Balev Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03027570

Collaborator

University of Haifa (Other)

100

Enrollment

Location

Arms

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of overweight children.The intervention group will use the app "Just Dance Now" and The control group will be exposed to the usual program without the app. Measurements will be performed at the beginning of the program, the end and 3 months after completion of the intervention.

Condition or Disease	Intervention/Treatment	Phase
Body Mass Index Blood; Sugar, High Lipid Disorder Body Image	Behavioral: Control Behavioral: Exergame activity_EXG Other: Application activity	N/A

Detailed Description

80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers for the treatment of overweight children. The intervention group will use the app "Just Dance Now" and part of a weekly exercise session will be dedicated to a group app activity. The control group will be exposed to the usual program without the app.

Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and questionnaires regarding attitude and response to physical activity will be performed at the beginning of the program, the end and 3 months after completion of the intervention. Participation in the sessions will be documented and home activity recorded using a weekly log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children

Actual Study Start Date :

Mar 2, 2017

Actual Primary Completion Date :

Jun 6, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Five-month program at two centers for the treatment of overweight children.	Behavioral: Control Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.
Experimental: Exergame activity_EXG Adding an exergame activity application to the regimen at a center for the treatment of overweight children.	Behavioral: Exergame activity_EXG In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app "Just Dance Now" and part of a weekly exercise session will include a group activity with the app. Other: Application activity The application - "Just Dance Now" will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.

Arm

Intervention/Treatment

Experimental: Control

Five-month program at two centers for the treatment of overweight children.

Behavioral: Control

Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.

Experimental: Exergame activity_EXG

Adding an exergame activity application to the regimen at a center for the treatment of overweight children.

Behavioral: Exergame activity_EXG

In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app "Just Dance Now" and part of a weekly exercise session will include a group activity with the app.

Other: Application activity

The application - "Just Dance Now" will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.

Outcome Measures

Primary Outcome Measures

Changes in Body Mass index (BMI) score [5-8 months]

Secondary Outcome Measures

Changes in Behavioral Regulation in Exercise [5-8 months]
Determined using an Exercise regulation questionnaire (BREQ-2)
Changes in Physical Self-Perception Profile [5-8 months]
Determined using a Physical Self-Perception Profile questionnaire (PSPP).
Changes in Response toward home physical activity [5-8 months]
By filling a weekly activity log.
Changes in Response toward physical activity sessions [5-8 months]
By filling physical activity session attendance.
Changes in Level of physical activity [5-8 months]
By using a Physical Activity Questionnaire - for elementary School (PAQ-C).
Blood sugar profile [5-8 months]
By measuring levels of HBAa1c and fasting glucose.
Blood lipid profile [5-8 months]
By measuring levels of ADL, HDL, and Triglycerides.
Aerobic capacity [5-8 months]
By using Modified YO-YO IR1 field test to estimate VO2Max levels.
Speed and Agility [5-8 months]
By using 10*4 - Shuttle Run field test.
Leg endurance ability [5-8 months]
By using Wall Sit up field test.
Lower limb explosive power [5-8 months]
By using Standing Long Jump field test.
Forearm muscle strength [5-8 months]
By using a hand grip failed test.
Coordination levels [5-8 months]
By using Modified Alternate Hand Wall Toss filed Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children aged 5-13 from the center for the treatment of overweight children in the MACABI health organization
BMI≥85%.

Exclusion Criteria:

Children with physical disabilities, that don't allow participation in physical activity during the study.
Children who don't own a mobile phone or don't have an access to a computer to activate the app for one hour a day.
BMI<85%